TSF 71935754

GUDID 00885556725238

SLOTTED FIXATION BOLT 1.2MM WIRE

Smith & Nephew, Inc.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00885556725238
• NIH Device Record Key: f7f38b56-3a0d-456b-b1cb-1ed15a7c2336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSF
• Version Model Number: 71935754
• Catalog Number: 71935754
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556725238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994143

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

[00885556725238]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-18

On-Brand Devices [TSF]

• 00885556725412: ACCESSORY SINGLE ROW 2-3 RING 90MM
• 00885556725405: ACCESSORY SINGLE ROW 2-3 RING 80MM
• 00885556725238: SLOTTED FIXATION BOLT 1.2MM WIRE
• 00885556725221: ACCESSORY SINGLE ROW FULL RING 90MM
• 00885556725214: ACCESSORY SINGLE ROW FULL RING 80MM
• 00885556685952: SMOOTH WIRE FOR SMALL BONE FIXATOR 1.2MM
• 00885556685945: ACCESSORY SINGLE ROW 2/3 RING 130MM
• 00885556685938: ACCESSORY SINGLE ROW 2/3 RING 105MM
• 00885556534625: SPATIAL FRAME 2/3 RING 105MM BLUE
• 00885556534618: SPATIAL FRAME 2/3 RING 105MM PINK
• 00885556498354: SPATIAL FRAME 2/3 RING 130MM GREEN
• 00885556498309: SPATIAL FRAME 2/3 RING 130MM BLUE
• 00885556498255: SPATIAL FRAME 2/3 RING 130MM PINK
• 00885556498200: SPATIAL FRAME 2/3 RING 105MM GREEN
• 00885556783825: COMBINATION WRENCH 10MM OPEN/BOX END
• 00885556783795: WRENCH 8MM
• 00885556783788: OPEN ENDED WRENCH 10MM X 13MM 18CM
• 00885556783740: WRENCH 10MM FLEX HEAD
• 00885556783801: TUBULAR ANGULATED WRENCH 10MM
• 00885556783764: WRENCH 16MM FOR OSTEOTOMES
• 00885556783757: SMART TSF RATCHET WRENCH
• 00885556871300: THIN WRENCH